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REFRAMEd - REFRactory depression: Mechanisms and Effectiveness of radically open-dialectical behaviour therapy

REFRAMEd - REFRactory depression: Mechanisms and Effectiveness of radically open-dialectical behaviour therapy: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN85784627
Enrollment
276
Registered
2011-08-10
Start date
2012-01-01
Completion date
Unknown
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Mental and Behavioural Disorders Recurrent depressive disorder, unspecified

Interventions

Current interventions as of 17/06/2014: Radically Open Dialectical Behaviour Therapy for over-controlled behaviours followed up at 12 months. Previous interventions:

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 15/08/2012: 1. Aged 18 years or over 2. Have a current diagnosis of major depressive disorder (MDD; as defined by SCID-I) 3. Have refractory depression (RD), operationalized as having had two or more previous episodes of depression or meeting the criteria for chronic depression 4. Currently taking antidepressant medication 5. Have received this medication for 6 weeks or more at BNF recommended doses 6. Have a Hamilton Depression Rating score of at least 15 Previous inclusion criteria until 15/08/2012: 1. Aged 18 years or over 2. Have a current diagnosis of major depressive disorder (MDD) 3. Have a HAMD score of at least 15 4. Have treatment resistant depression (TRD) as defined by two or more previous episodes of depression and in their current episode to have taken an adequate dose of ADM for more than 6 weeks without symptom relief 5. Male and female participants

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 15/08/2012: 1. IQ less than 70 or insufficient English to complete treatment and assessment 2. Meet DSM-IV criteria for dramatic-erratic PD (borderline, histrionic, antisocial or narcissistic PD), bipolar depression, or psychosis 3. Have a primary diagnosis of substance dependence or substance abuse disorder 4. Currently receiving standard DBT 5. On a waiting list for standard DBT 6. Have received standard DBT within the last 6 months (please note that patients who have completed a course of DBT more than 6 months ago are eligible if they meet all other criteria) Previous exclusion criteria until 15/08/2012: 1. Have an IQ < 70 or insufficient English to complete treatment and assessment 2. Meet DSM-IV criteria for emotionally undercontrolled PD (borderline, histrionic, antisocial, narcissistic PD), bipolar depression or psychosis 3. Have a primary diagnosis of substance dependence or substance abuse disorder

Design outcomes

Primary

MeasureTime frame
Hamilton Rating Scale for Depression measured before treatment, after treatment, 6 months after treatment, and 12 months after treatment

Secondary

MeasureTime frame
1. Depression remission 2. Suicide ideation and behaviour 3. Health economics

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026